MedPath

Oleclumab

Generic Name
Oleclumab
Drug Type
Biotech
CAS Number
1803176-05-7
Unique Ingredient Identifier
5CRY01URYQ
Background

Oleclumab is under investigation in clinical trial NCT03819465 (A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC).

Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development

• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development. • FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer. • Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.

Innate Pharma Doses First Patient in Phase 1 Trial of Nectin-4-Targeting ADC IPH4502 for Advanced Solid Tumors

• Innate Pharma has initiated a Phase 1 clinical trial (NCT06781983) to evaluate the safety and tolerability of IPH4502 in patients with advanced solid tumors expressing Nectin-4. • IPH4502 is a novel antibody-drug conjugate (ADC) that targets Nectin-4, a cell adhesion molecule overexpressed in various solid tumors, including urothelial carcinoma and lung cancer. • The Phase 1 trial is an open-label, multi-center study that includes dose escalation and optimization phases, aiming to enroll approximately 105 patients with different types of advanced solid tumors. • Preclinical data suggest that IPH4502 is well-tolerated and demonstrates anti-tumor activity, offering a potential new therapeutic option for patients with limited treatment options.

ESMO 2024: Novel Approaches in Personalized Medicine and AI Highlighted

• The PIONeeR trial explored novel immunotherapy combinations to overcome resistance to PD-1/PD-L1 inhibitors in advanced NSCLC, but did not meet its primary endpoint of improved disease control. • The Rome trial demonstrated that genomic-guided therapy significantly improved objective response rate and progression-free survival in pretreated patients with metastatic solid tumors. • Prov-GigaPath, a novel AI foundation model, shows promise in predicting genomic alterations and analyzing the tumor microenvironment from pathology slides, enhancing personalized medicine.

Osimertinib-Based Regimens Lead Evolving Treatment Strategies for EGFR-Mutated NSCLC

• Osimertinib, alone or with chemotherapy, is now a preferred first-line treatment for EGFR-mutated NSCLC, particularly for patients with brain metastases. • The FLAURA2 trial demonstrated improved progression-free survival with osimertinib plus chemotherapy, leading to its integration into NCCN guidelines. • Clinical discussions emphasize balancing efficacy and toxicity when choosing between osimertinib monotherapy and combination regimens, considering patient-specific factors. • Emerging data suggest potential benefits of ctDNA analysis and novel agents in optimizing treatment strategies for EGFR-mutated NSCLC.

Sanofi Expands Oncology Pipeline with CD73 Inhibitor Ulelimumab Collaboration

• Sanofi partners with I-Mab to develop ulelimumab, a monoclonal antibody targeting CD73, for cancer treatment. • A pivotal study in China is evaluating ulelimumab with Loqtorzi in first-line NSCLC patients with PD-L1 and CD73-positive tumors. • Phase 1/2 trials showed a 63% ORR in NSCLC patients with high CD73 and PD-L1 expression when ulelimumab was combined with Loqtorzi. • The collaboration marks Sanofi's third oncology deal recently, focusing on innovative approaches in a competitive CD73-targeting landscape.

Advancements in HER2-Mutant NSCLC Therapies: A Pipeline Overview

• Several companies are actively developing novel therapies for HER2-mutant non-small cell lung cancer (NSCLC), indicating a robust pipeline. • Key players like AstraZeneca and Dizal Pharmaceuticals are advancing treatments such as Trastuzumab deruxtecan and DZD-9008 through clinical trials. • Clinical trials are evaluating the efficacy and safety of various therapeutic approaches, including tyrosine kinase inhibitors and antibody-drug conjugates. • These emerging therapies aim to address unmet needs in HER2-mutant NSCLC, offering potential improvements in treatment outcomes.

Monalizumab Shows Promise in NeoCOAST-2 Trial for Early-Stage NSCLC

• Interim results from the NeoCOAST-2 Phase 2 trial show monalizumab, combined with durvalumab and chemotherapy, demonstrates encouraging clinical outcomes in early-stage NSCLC. • The monalizumab arm achieved a pathological complete response rate of 26.7% and a major pathological response rate of 53.3% in resectable NSCLC patients. • Monalizumab, targeting the NKG2A receptor, aims to enhance anti-tumor responses mediated by NK and T cells, potentially improving outcomes in NSCLC treatment. • The manageable safety profile and maintained surgical rate in the monalizumab arm support its further investigation in combination strategies for NSCLC.

Durvalumab Combinations Show Promise in Resectable NSCLC and High-Risk Breast Cancer

• In resectable NSCLC, adding datopotamab deruxtecan to durvalumab and chemotherapy led to a 34.1% pathologic complete response rate, exceeding historical benchmarks. • The Neo-CheckRay trial showed that adding durvalumab to neoadjuvant chemotherapy and SBRT doubled pathologic complete response rates in high-risk, HR-positive breast cancer. • Both studies demonstrated manageable safety profiles, supporting further investigation of these novel combinations in larger, randomized controlled trials.

Oleclumab Plus Chemotherapy Shows Promise in Metastatic Pancreatic Cancer

• A Phase Ib/II trial evaluated oleclumab, with or without durvalumab, combined with chemotherapy in metastatic pancreatic ductal adenocarcinoma (mPDAC). • The combination of oleclumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). • The study suggests oleclumab could offer a new treatment option for mPDAC, addressing a critical unmet need in this aggressive cancer. • Further research is warranted to confirm these findings and explore the full potential of oleclumab in pancreatic cancer treatment.

Ivonescimab and IBI363 Show Promise in Advanced Solid Tumors at ESMO 2024

• Ivonescimab demonstrates encouraging Phase II data in advanced triple-negative breast cancer, recurrent/metastatic head and neck squamous cell carcinoma, and metastatic microsatellite-stable colorectal cancer. • IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein combined with bevacizumab, shows promising anti-tumor activity in advanced colorectal cancer. • Updated Phase 3 MARIPOSA study results reveal significant overall survival improvement with amivantamab plus lazertinib over osimertinib in EGFR-mutant advanced NSCLC. • Sacituzumab govitecan and ifinatamab deruxtecan demonstrate activity in extensive-stage small cell lung cancer, offering potential new treatment options.
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